Inside Precision Medicine March 29, 2023
On Monday, the U.S. Food and Drug Administration (FDA) published draft guidance regarding the design of clinical trials that the agency hopes can support the accelerated approval (AA) applications for drugs in oncology clinical trials. Accelerated approval is frequently used in oncology trials due to the urgency of clinical need for treating some cancer indications and also because of existing intermediate clinical endpoints that suggest a likely clinical benefit.
“The FDA’s accelerated approval program has provided patients with cancer earlier access to novel treatments that can be practice changing,” said Richard Pazdur, MD, director of the FDA’s Oncology Center of Excellence. “Today’s draft guidance provides recommendations to sponsors for designing clinical trials to support accelerated approval. Building quality and efficiency...
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